Automated detection of performance characteristics in an injection training system

ABSTRACT

Various systems and methods are provided for injection training by collecting, processing, analyzing and displaying measured information associated with the delivery of an injection. Sensor-based measurements of a syringe&#39;s position and orientation in three-dimensional space are obtained and processed to provide metrics of a trainee&#39;s injection performance. The measurements can be combined with a digital model of a training apparatus to deliver a computer-generated, graphical depiction of the training injection, enabling visualization of the injection from perspectives unavailable in the physical world. The training injection execution, as reflected in the measured sensor-based data, can be reviewed and analyzed at times after, and in locations different than, the time and location of the training injection. Additionally, injection training data associated with multiple training injections can be aggregated and analyzed for, among other things, trends in performance.

INCORPORATION BY REFERENCE TO ANY PRIORITY APPLICATIONS

Any and all applications for which a foreign or domestic priority claimis identified in the Application Data Sheet as filed with the presentapplication are hereby incorporated by reference in their entirety under37 CFR 1.57.

This application is a continuation application of U.S. patentapplication Ser. No. 14/645,997, filed Mar. 12, 2015 and titled“AUTOMATED DETECTION OF PERFORMANCE CHARACTERISTICS IN AN INJECTIONTRAINING SYSTEM”, which claims benefit of U.S. Provisional PatentApplication No. 61/952,579, filed Mar. 13, 2014, and titled “COSMETICAND THERAPEUTIC TRAINING,” the entire disclosure of which is herebyincorporated by reference and made part of this specification as if setforth fully herein in its entirety.

This application is also related to U.S. patent application Ser. No.14/595,972, filed Jan. 13, 2015; U.S. patent application Ser. No.14/230,294, filed on Mar. 31, 2014; U.S. patent application Ser. No.14/521,267, filed on Oct. 22, 2014; U.S. patent application Ser. No.14/598,614, filed Jan. 16, 2015; U.S. Provisional Patent Application No.62/009,543, filed Jun. 9, 2014; and U.S. Provisional Patent ApplicationNo. 62/094,881, filed Dec. 19, 2014. The entire disclosure of each ofthe above-referenced items is hereby incorporated by reference and madepart of this specification as if set forth fully herein in its entirety.

BACKGROUND

The present application relates generally to cosmetic and therapeutictraining, and more specifically to systems, devices, and methods forcosmetic and therapeutic training.

A variety of medical injection procedures are often performed inprophylactic, curative, therapeutic, or cosmetic treatments. Injectionsmay be administered in various locations on the body, such as under theconjunctiva, into arteries, bone marrow, the spine, the sternum, thepleural space of the chest region, the peritoneal cavity, joint spaces,and internal organs. Injections can also be helpful in administeringmedication directly into anatomic locations that are generating pain.These injections may be administered intravenously (through the vein),intramuscularly (into the muscle), intradermally (beneath the skin),subcutaneously (into the fatty layer of skin), or by way ofintraperitoneal injections (into the body cavity). Injections can beperformed on humans as well as animals. The methods of administeringinjections typically vary for different procedures and may depend on thesubstance being injected, the needle size, or the area of injection.

Injections are not limited to treating medical conditions, but may bealso used to treat aesthetic imperfections or to perform restorativecosmetic procedures. Many of these procedures are performed throughinjections of various products into different parts of the body. Theaesthetic and therapeutic injection industry comprises two maincategories of injectable products: neuromodulators and dermal fillers.The neuromodulator industry commonly utilizes nerve-inhibiting productssuch as Botox®, Dysport®, and Xeomin®, among others. The dermal fillerindustry utilizes products administered by providers to patients forboth cosmetic and therapeutic applications, such as, for example,Juvederm®, Restylane®, Belotero®, Sculptra®, Artefill®, and others. Theproviders or injectors may include plastic surgeons, facial plasticsurgeons, oculoplastic surgeons, dermatologists, nurse practitioners,dentists, and nurses, among others.

One of the major problems in the administration of injections is thatthere is no official certification or training process. Anyone with aminimal medical related license may inject a patient. These “injectors”may include primary care physicians, dentists, veterinarians, nursepractitioners, nurses, physician's assistants, or aesthetic spaphysicians. However, the qualifications and training requirements forinjectors vary by country, state, and county. For example, in moststates in the United States, the only requirement to inject patientswith neuromodulators and/or fillers is a nursing degree or medicaldegree. This causes major problems with uniformity and expertise inadministering injections. The drawbacks resulting from a lack ofuniformity in training and expertise are widespread throughout themedical industry. Doctors and practitioners often are not well trainedin administering injections for diagnostic, therapeutic, and cosmeticpurposes. This lack of training often leads to instances of chronicpain, headaches, bruising, swelling, or bleeding in patients.

Current injection training options are classroom-based, with hands-ontraining performed on live models. The availability of models islimited. Moreover, even when available, live models are limited in thenumber and type of injections that may be performed on them. The needfor live models is restrictive because injectors are unable to beexposed to a wide and diverse range of situations in which to practice.For example, it may be difficult to find live models with different skintones or densities. This makes the training process less effectivebecause patients often have diverse anatomical features as well asvarying prophylactic, curative, therapeutic, or cosmetic needs. Livemodels are also restrictive because injectors are unable to practiceinjection methods on internal organs due to health considerations. As aresult of these limited training scenarios, individuals seekingtreatments involving injections have a much higher risk of being treatedby an inexperienced injector. This may result in low patientsatisfaction with the results, or in failed procedures. In manyinstances, patients have experienced lumpiness from incorrect dermalfiller injections. Some failed procedures may result in irreversibleproblems and permanent damage to a patient's body. For example, patientshave experienced vision loss, direct injury to the globe of the eye, andbrain infarctions where injectors have incorrectly performed dermalfiller procedures. Other examples of side effects include inflammatorygranuloma, skin necrosis, endophthalmitis, injectable-related vascularcompromise, cellulitis, biofilm formation, subcutaneous nodules,fibrotic nodules, and other infections.

Given the varying qualifications and training requirements forinjectors, there is currently no standard to train, educate, and certifyproviders on the proper and accurate process of various injectiontechniques. Patients seeking injections also have few resources fordetermining the qualifications or experience of a care practitioner.

Given the variety of injectable products, it is desirable to provideeffective, efficient, and extensible training injection systems,methods, and devices that cater not only to those products availabletoday but also to those yet to be deployed.

SUMMARY

The embodiments described herein provide distinct improvements toinjection training technology, namely the collection, processing,analysis, and display of measured information associated with thedelivery of an injection. In particular, sensor-based measurements of asyringe's position and orientation in three-dimensional space—as thesyringe delivers an injection into a training apparatus—are obtained andprocessed to provide metrics of a trainee's injection performance. Themeasurements can be combined with a digital model of the trainingapparatus to deliver a computer-generated, graphical depiction of thetraining injection as it occurs in real time as well as in replay afterthe training injection is competed. The graphical depiction providesimproved visibility into the injection by presenting, for example,different layers of tissue corresponding to the portion of anatomy beinginjected. Additionally, the computer-generated, graphical depictionenables visualization of the injection from perspectives unavailable inthe physical world. For example, the computer-generated, graphicaldepiction can display the syringe's needle tip within the anatomy as theinjection progresses. Viewed perspectives can be enlarged, reduced,rotated and panned to provide multiple perspectives of the injection.Sensor-based measurements of a pressure applied to a syringe plungerand/or to the training apparatus by the syringe can also be obtained andprocessed to provide additional metrics associated with a trainee'sinjection performance. Illustratively, measurements of pressure appliedto the syringe plunger can be processed along with position andorientation measurements to graphically depict a flow of therapeuticagent being delivered from the syringe to the anatomy.

The embodiments described herein also provide a distinct improvement tothe capability to monitor and evaluate injection training activity andperformance. The training injection execution, as reflected in themeasured sensor-based data, can be reviewed and analyzed at times after,and in locations different than, the time and location of the traininginjection. Additionally, one or more collections of injection trainingdata associated with multiple training injections performed by multipletrainees can be aggregated and analyzed for trends in performance. Acollection of injection training data can include one or moreinformation sets, where an information set can include data collectedduring an injection training session performed by a trainee using aninjection training system. The information set can include informationdescribing dynamic motion of the syringe as the syringe delivers thetraining injection to the training apparatus, information describing thetraining apparatus, and information describing the training session,among others.

The systems, methods, devices, and non-transitory, computer-readablemedia discussed herein include several aspects, no single one of whichis solely responsible for its desirable attributes. Without limiting thescope of the disclosed invention as expressed by the claims whichfollow, some features are discussed briefly below. After consideringthis discussion, and particularly after reading the section entitled“Detailed Description,” it will be understood how advantageous featuresof this disclosure include, among other things, improved injectiontraining.

In one aspect of the present disclosure, an injection training system isdescribed. The injection training system includes a training apparatus,a syringe, a display device, a training server, a data store, a trainingportal, and one or more networks configured to enable communicationbetween the training apparatus, the syringe, the display device, thetraining server, the data store, and the training portal. The trainingapparatus includes a training portion that is configured to represent anobject to which a training injection may be delivered and to receive thetraining injection delivered by the syringe. The training portion of thetraining apparatus can be configured to represent, by way ofnon-limiting examples, the following: an anatomy, a part of an anatomy,a human anatomy, a part of a human anatomy, a training and certificationhead, a human head, a human face, a non-human anatomy, a part of anon-human anatomy, an inanimate object, and a mechanical device.

In some embodiments the training apparatus further comprises anapparatus sensor. The apparatus sensor can be located external to,internal to, or integrated into the training apparatus. The apparatussensor can be configured to obtain apparatus sensor informationassociated with one or more characteristics of the syringe as thesyringe is used to deliver the training injection to the trainingportion of the training apparatus. Illustratively, the apparatus sensorinformation can correspond to the position and orientation of thesyringe as it delivers the injection to the training apparatus,including by way of non-limiting example, a video feed or other signalindicative of detected light, a sensor position value relative to alongitudinal axis, a sensor position value relative to a lateral axis, asensor position value relative to a vertical axis, a sensor positionroll value, a sensor position pitch value, a sensor position yaw value,and a sensor profile characteristic. In some embodiments the apparatussensor comprises an optical measurement and tracking system configuredto measure information corresponding to a three-dimensional position andorientation of the syringe. In some embodiments the apparatus sensorcomprises a three-dimensional tracking system comprising at least twostereoscopic cameras. In other embodiments, the apparatus sensorcomprises a first camera positioned within a hollow portion of the ofthe training apparatus, where the first camera has a first center point;a second camera positioned within the hollow portion of the trainingapparatus, where the second camera has a second center point; andwherein the first center point is aligned with the second center point,and wherein the first and second cameras are configured to operatestereoscopically.

In an aspect of the present disclosure, the syringe includes a syringesensor configured to obtain information associated with one or morecharacteristics of the syringe as the syringe delivers the traininginjection to the training portion of the training apparatus. The syringesensor can be located external to, internal to, or integrated into thesyringe. In some embodiments the syringe sensor comprises a magnetometerconfigured to measure information corresponding to characteristics of amagnetic field, including the earth's magnetic field. The magnetometercan be configured to measure information corresponding tocharacteristics of a magnetic field with respect to one, two, or threedimensions. In some embodiments the syringe sensor comprises anaccelerometer configured to measure information corresponding tocharacteristics of a linear acceleration of the syringe, and can beconfigured to measure information corresponding to characteristics of alinear acceleration of the syringe with respect to one, two, or threedimensions. In some embodiments the syringe sensor comprises a gyroscopeconfigured to measure information corresponding to characteristics of anangular velocity of the syringe, and can be configured to measureinformation corresponding to characteristics of an angular velocity ofthe syringe with respect to one, two, or three dimensions. In someembodiments the syringe sensor comprises an inertial measurement sensorconfigured to measure information corresponding to a position andorientation of the syringe, and can be configured to measure informationcorresponding to the position and orientation of the syringe withrespect to one, two, or three dimensions. In some embodiments thesyringe sensor comprises a pressure sensor configured to captureinformation corresponding to a position of a needle tip of the syringeas the syringe delivers the training injection to the training portionof the training apparatus.

In yet another aspect of the present disclosure, the training apparatusincludes a base portion comprising an apparatus sensor interfaceconfigured to receive the apparatus sensor information and a processorconfigured to process the apparatus sensor information, the processorfurther configured to transmit to, the display device and/or to theserver, the apparatus sensor information.

In some embodiments of the disclosed injection training system, thetraining apparatus comprises a training portion configured to representan object to which an injection may be delivered, where the trainingportion is further configured to receive the training injectiondelivered by the syringe; a sensor configured to obtain sensorinformation associated with a characteristic of the syringe as thesyringe is used to deliver the training injection to the trainingportion of the training apparatus; and a base portion comprising: asensor interface configured to receive the sensor information from thesensor; and a processor configured to process the sensor information,the processor further configured to transmit, to the display deviceand/or to the server, the sensor information. In some embodiments theprocessor is further configured to transmit, to the display deviceand/or to the server, the sensor information and/or the processed sensorinformation.

In some embodiments of the disclosed injection training system, thesyringe comprises a syringe sensor configured to obtain syringe sensorinformation associated with a characteristic of the syringe as thesyringe is used to deliver the training injection. The sensor interfaceis configured to receive the syringe sensor information and theprocessor is configured to transmit, to the display device and/or to theserver, the processed sensor information and the processed syringesensor information.

In another aspect of the disclosed injection training system, the baseportion of the training apparatus further comprises a syringe interfaceconfigured to receive, from the syringe, syringe information associatedwith a characteristic of the syringe as the syringe is used to deliverthe training injection to the training portion of the trainingapparatus; a sensor processor configured to process the sensorinformation; a syringe processor configured to process the syringeinformation; a memory device configured to store information; and anetwork input/output interface configured to transmit and receiveinformation by way of a network. In some embodiments the base portionfurther comprises a display device input/output interface configured totransmit and receive information between the training apparatus and thedisplay device.

An embodiment of the disclosed injection training system comprises atraining syringe configured to deliver a training injection, thetraining syringe having a syringe sensor configured to obtain syringeinformation associated with a characteristic of the training syringe; adisplay device configured to present information associated with thetraining injection; and a training apparatus comprising: a trainingportion configured to represent an object to which the traininginjection may be delivered and to receive the training injection, thetraining portion comprising an apparatus sensor configured to obtainapparatus information associated with a characteristic of the trainingsyringe relative to the training portion of the training apparatus; anda base portion configured to receive and to process the syringeinformation and the apparatus information, the base portion furtherconfigured to transmit the syringe information and the apparatusinformation to the display device. In some embodiments the base portionof the training apparatus further comprises a processing unit thatcomprises a sensor interface configured to communicate with the syringesensor and with the apparatus sensor; a processor, coupled to the sensorinterface, the processor configured to process the syringe informationand the apparatus information; a memory device, coupled to theprocessor, the memory device configured to store information; and anetwork interface configured to transmit and receive information over anetwork.

In some embodiments the base portion further comprises a syringe sensorinterface configured to communicate with the syringe sensor; anapparatus sensor interface configured to communicate with the apparatussensor; a syringe sensor processor configured to receive and to processthe syringe information; an apparatus sensor processor configured toreceive and process the apparatus information; a memory device, coupledto the syringe sensor processor and to the apparatus sensor processor,the memory device configured to store information; and a networkinterface configured to transmit and receive information over a network.The base portion further comprises a display device interface configuredto transmit and receive information between the training syringe, thetraining apparatus, and the display device.

Another embodiment of the disclosed injection training system comprisesa training apparatus configured to receive a training injection; asyringe configured to deliver the training injection; a display devicein communication with the training apparatus and with the syringe; aserver in communication with the display device; a training portal incommunication with the server; and a data store in communication withthe server. In some embodiments the server is in communication with thetraining apparatus and with the syringe.

Yet another embodiment of the disclosed injection training systemcomprises a training syringe having a needle and a position sensor,where the position sensor is configured to obtain position informationcorresponding to the training syringe; an injection apparatus configuredto receive a training injection by the training syringe; a processingunit, having a processor and a memory device, wherein the processingunit is configured to receive and to process the position informationand to transmit the position information and/or the processed positioninformation; and a display device configured to receive the positioninformation and/or the processed position information to displayposition data reflective of the position information. The positionsensor is further configured to obtain multiple measurements of positioninformation of the training syringe over time. In an embodiment, theprocessor is configured to determine a location of the needle withrespect to an injection site on the injection apparatus and to displaythe determined location of the needle with respect to an injection siteon the display device. In some embodiments the displayed location of theneedle comprises an animated depiction of the needle in relation to theinjection site on the injection apparatus.

In some embodiments the position sensor comprises an inertialmeasurement unit. The inertial measurement unit can, in someembodiments, include a first sensor configured to measure angularvelocity information, a second sensor configured to measure linearacceleration information, and a third sensor configured to measuremagnetic field information. In some embodiments the position sensorincludes a first sensor configured to measure angular velocityinformation, a second sensor configured to measure linear accelerationinformation, and a third sensor configured to measure magnetic fieldinformation. In some embodiments the first sensor measures angularvelocity information in three dimensions, the second sensor measureslinear acceleration information in three dimensions, and the thirdsensor measures magnetic field information in three dimensions. In someembodiments the first sensor comprises a gyroscope, the second sensorcomprises an accelerometer, and the third sensor comprises amagnetometer. In some embodiments the processor is further configured toprocess the measured nine dimensions of information to determine anestimate of position and orientation of the training syringe inthree-dimensional space.

In an embodiment, the injection apparatus further comprises a trainingportion comprising: an at least partially hollow base structureconfigured to provide structural support; a clear layer of elastomercoating at least partially covering the base structure; an opaque layerat least partially covering the clear layer, wherein the base structure,clear layer, and opaque layer form an anatomical shape; and an apparatussensor configured to determine a location of the needle when the needleis inserted into the clear layer of elastomer. In some embodiments, theapparatus sensor is positioned inside the at least partially hollow basestructure of the training portion of the injection apparatus. In someembodiments the apparatus sensor comprises a three-dimensional trackingsystem, and wherein the three-dimensional tracking system is furtherconfigured to track multiple locations of the needle over time. In someembodiments, the three-dimensional tracking system comprises a camera,in some embodiments the three-dimensional tracking system comprises atleast two cameras configured to operate stereoscopically, and in someembodiments the three-dimensional tracking system comprises an array oflight sensors. In some embodiments the needle of the training syringecomprises a distal tip configured to emit a light therefrom. In someembodiments the three-dimensional tracking system is configured todetermine the location of the needle based on a measurement of one ormore characteristics of an emission from the needle. In some embodimentsthe emission is light, and the characteristics of the emission includeintensity, angle, dispersion, brightness, color, and duration of thelight.

In another aspect of the present disclosure, a method to improveperformance of an injection technique is described. The method comprisesobtaining injection information associated with a training injection ofthe injection technique; analyzing the injection information; andrecommending, based on the analyzed injection information, an action toimprove injection technique. The method can further comprise evaluatingthe injection information relative to at least one evaluation criterion.The injection information can include: a target location for thetraining injection; a location on a training apparatus where thetraining injection was delivered; a determination of whether thetraining injection was delivered to the target location; a depth of thetraining injection; an amount of therapeutic agent delivered by thetraining injection; a duration of the training injection; an angle ofentry of the training injection; a determination as to whether thetraining injection passed or failed an injection test; a score; anaccuracy rating; an overall rating; and an average score for thetraining injection performed when performed more than once. Evaluatingthe injection information relative to at least one evaluation criterioncan comprise comparing the obtained injection information with at leastone performance requirement to determine whether the training injectionmet the at least one performance requirement. Analyzing the injectioninformation can comprise obtaining injection information associated witha previous training injection of the injection technique and comparingthe previous injection information to the obtained injectioninformation. In some implementations, analyzing the injectioninformation comprises obtaining aggregated injection informationassociated with a plurality of previous training injections (alsoreferred to as one or more collections of injection training data) ofthe injection technique and comparing the aggregated injectioninformation with the obtained injection information. Recommending, basedon the evaluated injection information, an action to improve injectiontechnique comprises identifying training resources directed at an aspectof the injection technique.

In yet another aspect of the present disclosure, a non-transitory,computer-readable medium having stored thereon executable instructionsthat direct a computing device to perform an injection training processis disclosed. The injection training process comprises the followingexecutable components: a registration component configured to obtaininformation associated with a user of an injection training system, andbased on the obtained information, to establish an account associatedwith the user; a login component configured to provide, to the user,access to the injection training system when the user authenticates theuser's identity; a personal homepage component configured to provideinformation associated with the user; a training component configured todeliver a training activity to be performed by the user; a trainingresults component configured to present results of the training activityperformed by the user; a certification test component configured todeliver a certification test activity to be performed by the user; acertification determination component configured to determine whetherthe user passed the certification test; and a certification deliverycomponent configured to publish and distribute a certificate indicatingthat the user passed the certification test activity. In someimplementations, the registration component is further configured toobtain biometric information of the user, and the login component isfurther configured to authenticate the user based at least in part onthe biometric information. The biometric information can include atleast one of the following: a fingerprint, a retina image, a facialimage, an image of palm veins, a sample of DNA, a palm print, a handgeometry, an iris image, a voice print, an odor, and a scent. In someimplementations the certification delivery component is configured tocreate a record in the injection training system indicating that theuser passed the certification test activity.

In another aspect of the present disclosure, a method to generate aprofile of a trainee in an injection training system is described. Themethod comprises: receiving, from the trainee, a request to generate thetrainee profile; obtaining training and test information associated withthe trainee; obtaining resources to be accessed by the trainee;obtaining injection information associated with the trainee; obtainingtraining offerings purchased for the trainee; obtaining certificationsfor the trainee; generating analytics based, at least in part, ontraining performed by the trainee; and generating the profile of thetrainee. The training and test information associated with the traineecan include resources to be accessed by the trainee, injectioninformation associated with the trainee, training offerings purchasedfor the trainee, and certifications for the trainee are obtained atleast in part, from a data store within the injection training system.In some implementations, generating analytics based on trainingperformed by the trainee further comprises: obtaining, from theinjection training system, aggregated information associated withtraining performed by at least one injector other than the trainee;analyzing the aggregated information to determine an average trainingperformance level; and assessing a performance level of the traineerelative to the average training performance level. In someimplementations generating analytics based on training performed by thetrainee further comprises: obtaining, from the injection trainingsystem, aggregated information associated with training performed by atleast one injector other than the trainee; and identifying, from theobtained aggregated information, one or more injection behaviorsassociated with injection techniques that are used by successfulinjectors. In some implementation, generating analytics based ontraining performed by the trainee further comprises: obtaining, from theinjection training system, a collection of injection training dataassociated with training performed by at least one injector other thanthe trainee; analyzing the collection of injection data to determine anaverage training performance level; and assessing a performance level ofthe trainee relative to the average training performance level.

In another aspect of the present disclosure, a method for injectiontraining is described. The method comprises receiving a messageidentifying a trainee; obtaining a training module that identifies atarget injection profile for a specified injection site and for aspecified injection substance, wherein the target injection profileincludes characteristics of a desired injection outcome for thespecified injection site and injection substance; obtaining injectiondata reflective of a training injection performed by the trainee, theinjection data including at least one characteristic associated with asyringe used to deliver the training injection; analyzing the injectiondata relative to the target injection profile; and providing feedback,to the trainee, based at least in part on the obtained injection data.

In another aspect of the present disclosure an injection system isdescribed. The injection system comprises a plurality of trainingapparatus, each training apparatus including a training portion and asyringe; a training server in data communication with said plurality oftraining apparatus, said training server configured to transmit andreceive injection information from one or more of said plurality oftraining apparatus, said injection information identifying one or morecharacteristic of the associated syringe during a training session for aparticular training apparatus of said plurality of training apparatus;and a display device in data communication with at least one of saidplurality of training apparatus and said training server, said displaydevice configured to view said injection information for the at leastone of said plurality of training apparatus.

In yet another aspect of the present disclosure, an injection trainingapparatus is described. The training apparatus comprises a trainingportion including a sensor; a syringe including an emitter configured togenerate an emission detectable by the sensor; and a housing coupled toand supporting the training portion, the housing including: means forcommunicating with the sensor; means for communicating with the syringe;means for transmitting information obtained from the sensor and thesyringe via a network, the information indicative of one or morecharacteristic of the syringe during a training session; and means forreceiving training information, including configuration information, forat least one of the sensor and the syringe, the configurationinformation indicative of an injection test for an injectable substanceat an injection site on the training portion.

In another aspect of the present disclosure a method of injectiontraining is described. The method comprises receiving an electronicmessage identifying a trainee; transmitting a training module to anembedded processing unit, said training module identifying a targetinjection profile for specified injection site and injectable substance;after completion of said training module, receiving injection data forthe trainee for the training module, said injection data identifying oneor more characteristic of a syringe during the training, said injectiondata associated with a training apparatus upon which said trainingmodule was performed; and providing feedback, based at least in part, onsaid received injection data.

In another aspect of the present disclosure a non-transitory,computer-readable medium including instructions executable by aprocessor of an electronic device is described. The instructions causethe electronic device to receive an electronic message identifying atrainee; transmit a training module to an embedded processing unit, saidtraining module identifying a target injection profile for specifiedinjection site and injectable substance; after completion of saidtraining module, receive injection data for the trainee for the trainingmodule, said injection data identifying one or more characteristic of asyringe during the training, said injection data associated with atraining apparatus upon which said training module was performed; andprovide feedback based at least in part on said received injection data.

In yet another aspect of the present disclosure an injection trainingsystem is described. The injection training system comprises a trainingapparatus configured to receive a training injection; a syringe, havinga needle, the syringe configured to deliver the training injection; adisplay device in communication with the training apparatus and with thesyringe, the display device having at least one processor, the processorcausing a view to be displayed on the display device; and a server incommunication with the display device. In some embodiments, the view tobe displayed comprises at least one of a login interface view, apersonalized profile page view, a progress dashboard view, a trainingmode interface view, a training resources view, a training view, atraining results view, a certification mode view, a certification testinterface view, and a certification interface view.

In another aspect of the present disclosure a method to analyze acollection of injection training data is described. The method comprisesreceiving the collection of injection training data, the collection ofinjection training data comprising information sets, wherein aninformation set comprises data collected during an injection trainingsession performed by a trainee using an injection training system,wherein the injection training system comprises a training apparatusconfigured to receive a training injection, a syringe, having a needleand a plunger, the syringe configured to deliver the training injection,and at least one sensor configured to sense information associated withthe training session. The information set comprises informationdescribing dynamic motion of the syringe as the syringe delivers thetraining injection to the training apparatus; information describing thetraining apparatus; and information describing the training session. Themethod further comprises converting the collection of injection trainingdata by grouping various types of data into a same format and assigninga label indicating a category of item contents, such that the convertedcollection of injection training data is in condition for traininginjection performance analysis; and generating an aggregate assessmentof injection training performance.

In some embodiments the at least one sensor comprises an inertialmeasurement unit positioned within the syringe, an optical measurementand tracking system configured to measure information corresponding to athree-dimensional position and orientation of the syringe, and/or athree-dimensional tracking system comprising at least two stereoscopiccameras configured to measure information corresponding to athree-dimensional position and orientation of the syringe. In someembodiments the information describing dynamic motion of the syringe asthe syringe delivers the training injection to the training apparatuscomprises a measure of force provided by a force sensor; a measure ofposition provided by a position sensor; and a measure of orientationprovided by the position sensor. In some embodiments the measure offorce provided by the force sensor corresponds to a force applied to theplunger of the syringe and is processed to determine of an amount oftherapeutic agent delivered by the training injection, or an estimate ofan amount of therapeutic agent simulated to have been delivered by thetraining injection. In some embodiments the measure of force provided bythe force sensor corresponds to a force applied to the trainingapparatus.

In an embodiment of the method to analyze a collection of injectiontraining data, the information describing dynamic motion of the syringeas the syringe delivers the training injection to the training apparatuscomprises: a measure of force provided by a force sensor; a measure ofposition provided by a position sensor; and a measure of orientationprovided by the position sensor. In some embodiments, the measure offorce provided by the force sensor corresponds to a force applied to theplunger of the syringe and is processed to determine an estimate of anamount of therapeutic agent delivered by the training injection. In anembodiment, the measured force applied to the plunger of the syringe isprocessed to determine an estimate of an amount of therapeutic agentsimulated to have been delivered by the training injection. In anotherembodiment, the measure of force provided by the force sensorcorresponds to a force applied to the training apparatus. In someembodiments, the measure of position provided by the position sensorcorresponds to a position of the syringe in three-dimensional space, andthe measure of orientation provided by the orientation sensorcorresponds to an orientation of the syringe in three-dimensional space.In some embodiments, the position sensor and the orientation sensorcomprise an inertial measurement unit. The inertial measurement unit canfurther comprise: a first sensor to measure linear acceleration; asecond sensor to measure angular velocity; and a third sensor to measuremagnetic force. In some embodiments, the first sensor comprises anaccelerometer, the second sensor comprises a gyroscope, and the thirdsensor comprises a magnetometer.

In some embodiments, the information describing dynamic motion of thesyringe as the syringe delivers the training injection to the trainingapparatus includes an angle of approach of the syringe needle relativeto the training apparatus; an angle of entry of the syringe needle intothe training apparatus; a depth of penetration of the needle within thetraining apparatus; an amount of force applied by the syringe to thetraining apparatus; an amount of therapeutic agent delivered to thetraining apparatus; an estimated amount of therapeutic agent simulatedto have been delivered to the training apparatus; a description ofdynamic displacement of the syringe plunger during the traininginjection; an amount of force applied to the syringe plunger during thetraining injection; a rate of flow of the therapeutic agent delivered tothe training apparatus; an estimated rate of flow of therapeutic agentsimulated to have been delivered to the training apparatus; a proximityof the delivered injection relative to a target injection site; or anidentification of an anatomical structure affected by the traininginjection.

In some embodiments, the information describing the training apparatuscomprises a digital model of the training apparatus based on informationcorresponding to the anatomical structure represented by the trainingapparatus, including, without limitation, a skin layer; a transparentskin layer; a muscle layer; a fat pad layer; a nerve layer; a bloodvessel layer; and a bone layer.

In some embodiments, the information describing the training sessionincludes, without limitation, a training date and time; a traininglocation; a trainee identity; a training session duration; a trainingscore; an injection time; and a pass/fail determination.

In some embodiments, the aggregate assessment includes, withoutlimitation, a ranking of injection performances reflected in thecollection of injection training data; a ranking of injectionperformances within a subgroup of injection performances reflected inthe collection of injection training data; information setscorresponding to an injection training session performed in a country, aregion, a city, or a practice group; a percentage comparison of aquantity of training injections performed by a first trainee relative toa quantity of training injections performed by all trainees representedin the collection of injection training data; a comparison of a traininginjection performed by a first trainee relative to a training injectionperformed by an expert in the field; or a comparison of traininginjections performed by all trainees represented in the collection ofinjection training data relative to a training injection performed by anexpert in the field.

For purposes of summarizing the disclosure, certain aspects, advantages,and novel features have been described herein. Of course, it is to beunderstood that not necessarily all such aspects, advantages, orfeatures will be embodied in any particular embodiment.

Described in further detail below are aspects of systems, methods,devices, and non-transitory computer-readable media for injectiontraining. The aspects may be combined, in whole or in part, withinjection training systems such as those from TruInject™ MedicalCorporation, assignee of the present application. While reference toTruInject™ Medical Corporation may be included in the description thatfollows, it will be understood that the aspects described herein may beapplied in other injection contexts and systems without departing fromthe scope of the present disclosure.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 illustrates an example of an injection training system in whichaspects of the present disclosure may be employed.

FIG. 2 shows a functional block diagram for an exemplary embodiment of atraining and certification head.

FIGS. 3-14 illustrate example displays which may be included in anembodiment of the disclosed injection training systems, methods,devices, and non-transitory computer-readable media.

FIG. 15 shows a process flow diagram for a method of providing injectiontraining according to an embodiment of the present disclosure.

FIG. 16 shows a process flow diagram for a method of generating atrainee profile according to an embodiment of the present disclosure.

FIG. 17 shows a process flow diagram for a method of providing injectiontraining according to an embodiment of the present disclosure.

FIG. 18 is a functional block diagram of an example general purposecomputer system suitable for use in the disclosed injection trainingsystems and for executing the disclosed methods and computer-readablemedia for injection training.

While the foregoing “Brief Description of the Drawings” referencesgenerally various embodiments of the disclosure, an artisan willrecognize from the disclosure herein that such embodiments are notmutually exclusive. Rather, the artisan would recognize a myriad ofcombinations of some or all of such embodiments.

DETAILED DESCRIPTION

The present disclosure generally relates to injection training systems,methods, devices, and non-transitory, computer-readable media.Illustratively, by way of non-limiting example, a trainee may practiceinjecting into a synthetic face using a syringe in combination with atraining and certification head (TCH). The TCH forms a head bust withrealistic look and feel of human flesh. The external surface of the TCHmay be a substantially synthetic or simulated skin. The synthetic orsimulated skin can be an opaque rubber or other material which simulatesskin and facial features of real patients. Underlying the skin may be alayer of substantially clear rubber (and/or any suitable elastomer orother material) that simulates the viscosity, elasticity, and feel ofskin, muscle, nerve, and bone tissue of a patient. The opaque skin andclear underlay may be capable of being pierced by a needle. The trainingand certification head and/or syringe may be configured to interact witha local display device (LDD) such as a tablet, notebook computer, orsmartphone, to name a few. The training and certification head, syringe,and/or LDD may also be configured to communicate with a training server.

The local display device is configured to show the angle and position ofthe needle tip reflecting information sent from the syringe and/or theTCH. The set of allowable training and certification modules for whichthe trainee is authorized to use may be provided by the training serverto the syringe and/or the TCH. The trainee or trainee facility may usethe system to enroll the trainee and/or to receive an indication ofpayment of fees. The local display device may be configured to provideinformation tailored to the trainee logged on to the syringe and/or theTCH. The LDD may display information received from the syringe and/orthe TCH and can receive an input message to change the syringe and/orthe TCH (and thus trainee) to which it is connected.

Testing performance data can include training pass/fail information, andcan also include information detailing the profile of the syringeinteraction with the TCH, which can be transmitted from the syringeand/or TCH to the training server. For example, performance feedback mayinclude whether the injection was made in the correct location, thedepth of the injection, and the areas in which the injection could havebeen improved. In one embodiment, performance feedback may includewhether a user passed or failed an injection test corresponding to acosmetic condition or therapeutic treatment. The results may also be inthe form of a score, an accuracy rating, or an overall rating.

Based on the injector's performance, there may be a score, rating orranking calculated and presented to a user requesting information on theinjector. The score, rating or ranking can provide an indication of anaccuracy of the injections performed, an estimated skill level of theinjector, an indication of the experience of the injector, a the numberof injections performed, or any other measure indicative of thecapability of the injector. A separate score or ranking may be availablefor different types of injections or injection locations.Illustratively, by way of non-limiting example, a patient searching foran injector experienced in treating crow's feet may access a list ofsuch injectors within a specified geographic area near the patient'slocation. The injectors may be listed by ranking, rating, or score basedon one or more of education, years of experience, performance resultswith the disclosed injection training system, or patient reviews. Thedata can also be collected from multiple patients or injectors andanalyzed to determine an average level of skill or patient satisfaction.Such performance data can be used to determine the effectiveness of, orthe risks associated with a particular treatment. This information maybe stored in a database and made available for information retrievalrelated to the injection training. One non-limiting advantage of thedescribed injection training features is to train optimally on aninjection technique to avoid or to correct adverse events. The trainingcan be optimized to process and provide information about the trainee'sinjection performance, ways to improve performance, and compliance withinjection best practices. The trainee's performance information can betransmitted to various parties, including the trainee, other medicalprofessionals, injection manufacturing companies, and insurancecompanies. The disclosed injection training system may also include afeature to provide public profiles of injectors who elect to make theirprofiles available. Illustratively, by way of non-limiting example,current or prospective patients may conduct online queries to search forinjectors based on, for example, clinical qualifications, geographicallocations, and the level of injection training and/or certificationcompleted. Security measures, known to those skilled in the art, tosafeguard information obtained from such queries may be practiced tocomply with regulations and to respect personal privacy.

Injection training may include providing a website accessible by thetrainee, health care provider, training company, or injectionmanufacturer. The website can provide utilities for the trainee and themanufacturing companies. The company information can be conveyed in asystem or format that provides security to exclude unauthorized access.For the trainee, the website can provide on-going tracking ofperformance, showing improvement in the trainee's injection techniquewhen using the injection training system. The trainee can access thesystem to perform activities related to injection training, review pasttraining sessions, and the like. One example of an activity ismonitoring performance on various training exercises over time. Thecompany receives all or a selected portion training data. The portionmay be selected based on the product, trainee, relationship between thetrainee and company (e.g., insured-insurer, hospital-provider). Thetraining data may be accumulated at a central records storage site andmade accessible for analytics, data mining, scheduling maintenance,product cross-selling, and similar activities.

FIG. 1 shows a network diagram of an example embodiment of an injectiontraining system 100. The injection training system 100 includes atraining apparatus 200 that is configured to receive a traininginjection delivered by a syringe 210. The syringe includes a needlehaving a needle tip at the distal end of the syringe, a barrel, aplunger at a proximal end of the syringe and configured to exert a forceon the barrel. In some embodiments the syringe 210 includes one or moresyringe sensors configured to obtain syringe sensor informationassociated with one or more characteristics of the syringe as it isbeing used to deliver a training injection. In some embodiments, thetraining apparatus 200 is configured to represent a human head and face,and may also be referred to as a training and certification head (TCH)200. The TCH 200 is configured to communicate via a network 104 with alocal display device 106, which may also be referred to herein as a“display device” 106. The network 104 may include one or more networkingtechnologies (e.g., satellite, LAN, WAN, cellular, peer-to-peer, etc.).The network 104 may be a public network (e.g., the Internet), or aprivate network (e.g., a virtual private network, also referred to as a“VPN”). The messages communicated via the network 104 can be transmittedand/or received using appropriate and known network transmissionprotocols (e.g., TCP/IP). In an embodiment, the TCH 200 can communicatedirectly with the local display device 106.

The local display device 106 may be an electronic communication deviceconfigured for wired or wireless network communications. The localdisplay device 106 includes a visual display such as a touchscreen,monitor, display screen, or the like. In some implementations, thevisual display may also be used as an input device, such as atouchscreen. In some implementations, an input device such as akeyboard, keypad, mouse, stylus, camera, biometric sensor, or the likemay be coupled with the local display device 106 and configured toprovide messages to the local display device 106.

The TCH 200 may also communicate directly or via the network 104 with atraining server 108. The training server 108 may provide informationabout a particular trainee via a training portal 110. The informationmay be stored in a data store 112. The data store 112 may be in directcommunication with the training server 108 or may be accessible via thenetwork 104. The data store 112 may be configured to maintain recordsfor trainees, exercise performance information, observation notes, andother training related data. The data store 112 may also be configuredto store training content such as the exercises, educational materials,instructional content, curricula organizing the instructional contentfor trainees, and the like. The training portal 110 may also beconfigured to provide a representation of the information about aparticular trainee and/or aggregated trainee information to thirdparties, such as a health care provider or a company administering atraining center where the training and certification head 200 islocated. In some implementations, the training portal 110 may receiveinformation from users and provide the input to the training server 108.For example, the training portal 110 may present a quiz to a trainee andreceive one or more answers to a question included in the quiz. Theresponsive inputs may be transmitted to the training server 108 andstored in the data store 112 with information associated with thetrainee. In an embodiment, a syringe 210 can also communicate wirelesslyor through a wired connection with the TCH 200, the local display device106, and/or the training server 108. In an embodiment, the syringe 210can communicate directly with the TCH 200 or through the network 104 tothe local display device 106 or to the training server 108.

Examples of information that may be uploaded to the training server 108and maintained in the data store 112 include training date and time;location; trainee; authorization code; session time; maximum score;maximum ranking within a group (national, region, city, affinity);injection time; amount of pressure applied to the syringe 210; track ofthe needle tip during injection; what muscle, nerve, or artery thesyringe 210 is in; pass/fail rates; percentage of injections versusother trainees; number of times injected (e.g., TCH/syringe 210associated with identifier 4203 has been injected 4500 times); behaviorof user “using” syringe 210 (e.g., gaming); report feedback on thetrainee's performance as compared to an expert (e.g., the Dr. JeanCarruthers technique); and how this injector “injects” versus others whohave undergone such training.

The training server 108 may be configured to analyze the received data.Illustratively, by way of non-limiting example, data can be mined fortrainee performance characteristics, including identification of theinjection behavior versus scoring, to identify specific techniques thatare used by the best injectors. The data may also be mined to identifytraining and certification heads 200 that need maintenance or replacing.The data may be mined further to identify effective training resourcesand/or training centers.

Examples of information that may be downloaded from the training server108 to the TCH 200 include current authorized training modules pertrainee; update protocols; and firmware updates, to name a few.

The local display device 106 may exchange messages with the trainingserver 108. Illustratively, such messages can relate to traineeregistration, certification and training inquires, purchasing of tests,accessing trainee certification history and related information,identifying the availability of training company resources (includingnational or local workshops), obtaining a list of certifiedtrainers/facilities, or trainee authentication/verification information(such as trainee-specific biometric information). In someimplementations, the local display device 106 may utilize a third-partybrowser-based service, such as Foursquare® or an equivalent, to allowpatients to locate local certified training facilities.

As shown in FIG. 1, the training portal 110 is hosted on a separatedevice from the training server 108. In some implementations, thetraining portal 110 may be included in the training server 108.

The local display device 106 may be configured to access the trainingserver 108 via the network 104. The local display device 106 may beconfigured to receive input regarding a particular training exercise fora particular trainee. For example, an observer may use the local displaydevice 106 to make a note about the test which may be used to evaluatethe test results. An example of such a note may be to document anequipment failure or an environmental change (e.g., power outage,earthquake) during the exercise.

FIG. 2 shows a functional block diagram of certain aspects of a trainingand certification head 200. The training and certification head 200 maybe similar to and/or include features of the testing tool shown anddescribed in the commonly assigned U.S. patent application Ser. No.14/067,829, filed on Oct. 30, 2013 and entitled “System for Cosmetic andTherapeutic Training,” which was incorporated herein by reference above.

The TCH 200 includes a training portion 202. When implemented as a humanfacial injection training system 100, the training portion 202 may beformed to resemble a human head. Other injection trainingimplementations, both human and non-human, are contemplated. Forexample, shoulder, leg, or other human body parts may be used as thetraining portion 202. The training portion 202 may be formed for dog,cat, horse, mouse, rat, iguana, or any other animal for injectiontraining. In such implementations, the training portion 202 may beformed to resemble all or a desired part of the animal. In someimplementations, the training portion 202 may be formed for mechanicaldevice injection training such as for use with engines, walls, orcomputing devices. The training portion 202 is connected to a baseportion 204.

The training portion 202 may be hollow. Inside the cavity, one or moreapparatus sensors 206 may be included to detect the location of asyringe 210. One exemplary embodiment of the one or more sensors 206shown in FIG. 2 is a camera. The camera is configured to detectcharacteristics of light which are emitted from the needle tip ofsyringe 210, which may be referred to as apparatus sensor information,or simply sensor information. Based on the detected characteristics, thelocation, depth, and other properties of the injection may bedetermined. The detected characteristics may include light intensity andcolor. In some implementations the apparatus sensor 206 may be amagnetometer. The magnetometer may detect characteristics of a magneticfield emitted by the syringe 210 to detect the location of the syringe210. Other sensors may be included and similarly configured to detectemissions from the syringe 210. In an embodiment, the syringe 210includes one or more sensors, including position sensors,accelerometers, 3D position sensors, orientation sensors, inertialmeasurement units, pressure sensors, or other sensors useful fordetermining position, location, orientation, and use characteristics ofthe syringe 210. The syringe 210 can be equipped with a wired orwireless communication device and can transmit the information to theTCH 200 or to another device that forms part of the injection trainingsystem 100. Additional examples of sensors that can be included on thesyringe 210 or TCH 200 include antenna to detect radio waves and amicrophone to detect sound. Combinations of sensors may be used toprovide additional detection capabilities.

The apparatus sensor 206 is coupled to a sensor interface 208, which isillustrated as a vision interface 208 in FIG. 2, housed within the baseportion 204. The coupling may include a wired, wireless, or hybridcoupling. In the implementation shown in FIG. 2, the vision interface208 is configured to transmit and receive information from the sensor206. The information transmitted to the sensor 206 may include trackinglocation coordinates (e.g., X, Y, and Z). The information transmittedfrom the sensor 206 may include one or more of a video feed or othersignal indicative of detected light, a sensor position pitch value, asensor position roll value, a sensor position yaw value, and/or a sensorprofile characteristic. The information may be transmitted from thesensor 206 to the vision interface 208.

The TCH 200 shown in FIG. 2 includes a processing unit 250. In someembodiments, by way of non-limiting example, the processing unit 250 maybe embedded within the base portion 204. The processing unit 250 may beimplemented as an embedded PC or other electronic information processingdevice (e.g., Raspberry Pi®, Arduino, BeagleBoard, etc.) included in thehousing 204. In some implementations, the processing unit 250 may beconfigured to include specialized circuitry to implement the aspectsshown in FIG. 2 and described herein. It may be desirable to configurethe processing unit 250, such as via non-transitory, computer-readablemedia storing software instructions executable by an electronicinstruction processing device(s), to implement the described features.

One feature included in the processing unit 250 shown in FIG. 2 is avision processor 252. The vision processor 252 is configured to exchangemessages with the sensor interface 208. While the description thatfollows is directed to vision information, it will be understood that asother sensors may be included in the TCH 200. Illustratively, additionalor alternate sensor processors may be included to similarly handle thesensor information exchanged between the sensor interface 208 and theprocessing unit 250.

In implementations where the sensor 206 is a camera, the visionprocessor 252 may receive information about the sensor such as a videofeed or other signal indicative of the detection of light and/or cameraposition (e.g., pitch, roll, yaw, sensor characteristic) or currenttracking position information (e.g., X, Y, and/or Z coordinates), orother forms of position information. Example sensor characteristicsinclude sensor type, sensor model number, sensor configuration, andsensor state (e.g., temperature, memory, processor load, etc.). Theinformation is received via the vision interface 208. In someimplementations, the vision processor 252 may transmit adjustmentinformation to the sensor 206 via the vision interface 208. For example,the tracking position may need to be adjusted for a particular test ortraining exercise. The tracking position may need to be adjusted toaccount for local testing variance (e.g., uneven installation surface,degradation of the TCH 200 over time, ambient lighting, temperature,etc.). The adjustments may be identified, in some implementations, bythe vision processor 252 based on one or more of the test or trainingexercises selected, a calibration sequence, configuration parameters(e.g., physical installation location information such as degreeslevel), or other inputs to the vision processor 252.

The processing unit 250 includes a processor 260. The processor 260 maybe configured to control the operation of one or more elements includedin the processing unit 250. For example, the processor 260 may beconfigured to provide adjustment instructions to the vision processor252. The processor 260 may operate by executing instructions stored in amemory 262. In some implementations, it may be desirable to configurethe processor 260 as an application-specific circuit configured toperform the features described herein. The memory 262 may also beconfigured to store information such as the information received fromthe vision processor 252. This information may be transmitted via anetwork input-output (I/O) interface 258. The network I/O interface 258may be configured to generate and receive messages over a network suchas the network 104 shown in FIG. 1. Messages may also be exchanged withthe syringe 210 or a local display device 106 via the local displaydevice I/O interface 256. In some embodiments, messages may be exchangedwith the syringe 210 or a local display device 106 via the network I/Ointerface 258. The local display device I/O interface 256 may generateand receive messages from a local display device 106 such as the localdisplay device 106 shown in FIG. 1.

Various elements of the processing unit 250 may be coupled by a bussystem 264. The bus system 264 may include a data bus, for example, aswell as a power bus, a control signal bus, and a status signal bus. Thebus system 264 is one example of a means for coupling the components ofthe processing unit 250. As such, the components of the processing unit250 may be coupled together or accept or provide inputs to each otherusing an alternative exchange mechanism.

The processing unit 250 may also receive information from the a sensorinterface, depicted in FIG. 2 as a syringe interface 212, via a syringeprocessor 254 included in the housing 204 of the TCH 200. The syringeinterface 212 may be configured to exchange messages with the syringe210. Messages may be received in real-time such that the characteristicsthe syringe 210 may be tracked during a test or training exercise. Thesyringe 210 may be configured for wired, wireless, or hybridcommunication with the syringe interface 212. For example, it may bedesirable to utilize a wireless communication technology such asBluetooth® for syringe 210 communications.

Messages transmitted to the syringe 210 may specify an injectionresistance profile, and/or an injection speed profile, and/or aninjection location profile. These profiles may be used to configure thesyringe 210 to provide realistic performance during a test. For example,one injectable fluid may have different characteristics than anothersuch as viscosity. The difference in viscosity can provide a differentexperience during the injection process. To ensure the test is asrealistic as possible, the resistance profile may be adjusted to reflectthe varying viscosity depending on the test or training exercise beingperformed.

Information received from the syringe 210 identifies the state of thesyringe 210 during a training exercise or test. The information mayinclude the color of fiber optic illumination, the intensity of fiberoptic illumination, the plunger base physical resistance, and theplunger travel limit. The plunger base physical resistance can provide avalue indicating the standard resistance for the syringe 210. Theplunger travel limit information provides information indicating thedegree to which the plunger on the syringe 210 has been depressed. Thisinformation can be used to calculate an amount of injectable fluiddelivered by the injection.

The syringe interface 212 may provide this information to the syringeprocessor 254. The syringe processor 254 may store the syringeinformation in the memory 262. The syringe processor 254 may also beconfigured to provide information to the syringe 210 via the syringeinterface 212. As with the vision processor 252, the syringe processor254 may adjust the parameters for the syringe 210 based on a test ortraining exercise being performed, or to account for changes in thetesting apparatus over time (e.g., degradation, environmentaladjustments, and the like).

It may be desirable, in some implementations, to provide visioninformation and/or syringe information to the local display device 106via the local display device I/O 256. The processor 260 may beconfigured to perform analytics on the vision and syringe data toprovide test or training exercise result information. For example, theprocessor 260 may obtain a test template for a given injectable andsite. The test template can provide expected injection locationinformation and syringe 210 injection characteristics, such as quantity,speed, and location. The processor 260 may compare the test or traininginformation with the template to determine how closely the trainee hasmatched the template.

In some implementations, the local display device I/O 256 may beimplemented as a webpage. In such an implementation, the local displaydevice I/O 256 may be an embedded Web server configured to generate HTMLor other machine readable documents for transmission to the localdisplay device 110. The local display device I/O 256 may also receivemessages from the local display device 110. For example, the localdisplay device 110 may be configured to monitor more than one TCH 200.In such implementations, the local display device 110 may transmit a TCHidentifier via the local display device I/O 256 and receive informationfor the activity at the identified TCH. The local display device 110 mayalso provide messages about an ongoing test or training exercise asdescribed above. The received information may be stored in the memory262.

The network I/O 258 may be configured to transmit test or traininginformation to the training server 108. As communication with thetraining server 108 is over the network 104, the time and resourceswhich may be consumed in providing the test or training information tothe training server 108 may be greater than the resources needed tocommunicate with a local display device. Accordingly, the processingunit 250 may be configured to delay transmission of the test or traininginformation from the memory 262 to the training server 108 until the endof a training or testing session. In some implementations, theprocessing unit 250 may be configured to transmit the information to thetraining server 108 based on a schedule. For example, it may bedesirable to transmit training or test information to the trainingserver 108 during a period of time when the training center is closed.At such a time, standard business network traffic may be at a minimum,thereby enhancing the efficiency of the transmission from the processingunit 250 to the training server 108. Another factor which may be usedfor determining the transmission time is the amount of storage spaceavailable in the memory 262. When a threshold usage amount is reached,the processing unit 250 may prepare to transmit data to the trainingserver 108 at the next available opportunity.

One non-limiting advantage of the described features includes theability to replace the training portion 202 without needing to replacethe housing 204. This can provide the ability for reconfiguring thesensor 206 and syringe processor 254 within the housing 204 toaccommodate different training portion configurations. This can beparticularly cost-effective when a training center provides differenttesting and/or training to a variety of clients. The processing unit 250may be reconfigured for a new training portion 202, thereby reducing theamount of setup needed to service a new training.

Another non-limiting advantage of the described features includes theability to adjust the training or testing for a given TCH 200 from thetraining server 108. For example, a trainee may be assigned to a TCH200. The trainee currently using the TCH 200 may be identified to thetraining server 108. Based on the identified trainee, the trainingserver 108 may provide one or more training modules which the trainee isauthorized to access. In this way, the processing unit 250 need onlyobtain the training information to which the currently logged-in traineehas access. This can reduce the processing and/or memory requirements tosupport multi-client training centers.

A further non-limiting advantage of the described features is to supportthe monitoring adjustment of the TCH 200 over time. Degradation inperformance of the TCH 200, sensor 206, or the syringe 210 may beidentified by analyzing the training or testing information transmittedfrom the TCH 200 to the training server 108. For example, traineeinformation for a given test may consistently exhibit common deviationfrom the expect test result. This may indicate a defect in the trainingand certification head 200. The number of tests performed may also beused to identify when the syringe 210 or training portion 202 may needmaintenance and/or replacement. Hardware typically exhibits apredictable degradation over time based on expected use. Using thisinformation, a TCH 200 which may be nearing end-of-life and/or requiringmaintenance can be identified, such as by the training server 108.

FIGS. 3-14 illustrate example embodiments of displays which may beincluded in an injection training system 100. FIG. 3 shows an embodimentof a login interface which may be used by a trainee to access theinjection training system 100. As shown, a login includes a username andpassword field. In some implementations, the login process may includebiometric information such as a fingerprint or retinal scan to helpverify the identity of the trainee. Biometric identifiers are thedistinctive, measurable characteristics used to label and describeindividuals. Biometric identifiers can be categorized as physiologicalcharacteristics related to the shape or structure of the body. Examplesof biometric identifiers include, without limitation, fingerprint, palmveins, facial image, DNA, palm print, hand geometry, voice print, iris,retina, and odor/scent. Behavioral characteristics, which may also beused to authenticate a user, are related to the pattern of behavior of aperson, including without limitation, typing rhythm, gait, and voice.Some researchers have coined the term “behaviometrics” to describe thebehavior-related class of biometrics.

FIG. 4 illustrates an embodiment of a personalized profile page for aclient. The personalized page may collect information about the trainee,such as activity summary, medical licensing, progress towardcertification, and the like. Interface elements may be included whichtransmit signals requesting additional training, to perform existingtraining, to perform certification, or to log out.

FIG. 5 shows an embodiment of a progress dashboard which may be includedin the training certification system. The progress dashboard illustratesone way in which such information may be represented. The informationshown includes a product and the number of hours trained on a givenproduct. For each product, an indication may be provided as to whetherthe certification has been completed and/or whether the trainee is readyto test for the certification.

FIG. 6 shows an embodiment of a training mode interface which may beused to perform training. A given trainee may not have access to all thetraining materials available through the system. As shown in FIG. 6, aninterface element may be included to receive a request to ordertrainings to which the trainee has not yet been authorized. FIG. 7 is anembodiment that illustrates training resources for a product. Thetraining resources may include audio, visual, multimedia, textual, andhaptic materials to help the trainee learn the techniques to qualify forand pass the certification. FIG. 8 is an embodiment that shows theavailable training for a particular location and product. As shown inFIG. 8, there is Botox® training available for the location of crow'sfeet. The training may include one or more tests. As shown in FIG. 8,the trainee has not performed any tests based on the absence of scoresfor each test. FIG. 9 is an embodiment that shows the available trainingfor a particular location in product after a trainee has performed thetests. Each test has an associated score expressed in this example as apercent. For the trainee data shown in FIG. 9, it appears the traineehas improved over time as the test score associated with the first testis 50% while the test score associated with the last test score is 90%.

The system may be configured to aggregate and analyze test results. FIG.10 is an embodiment that provides training results for the traineescores illustrated in FIG. 9. One analytic measure which may be providedis an average score. Another example of an analytic provided is astandard error which was identified in the trainee's performance. Asshown in FIG. 10, the trainee needs to focus on needle placement. Asidefrom simply identifying a weakness with the trainee, the system may alsoprovide suggested training materials to correct the weakness. As shownin FIG. 10, a recommended training is provided. Suggestions can bepredetermined (e.g., curricula based) or determined by the system overtime based on an analysis of the training data. For example, the systemmay determine that trainees who participate with a given training moduleexhibit a higher proficiency during testing than those who have notparticipated in the module.

A trainee may become eligible for certification for a given product.Illustratively, certification eligibility may be based on, for example,payment of a fee or, as another example, a number of training hourscompleted. As shown in the embodiment of FIG. 11, the trainee may selectcertification tests from the list. As shown, the trainee is eligible toperform certification for Botox®. The trainee may order additionalcertifications for which the trainee is eligible. When the trainee hasnot yet met the eligibility requirements for a particular product and/orprocedure, the trainee will not be permitted to order or perform thecertification test.

FIG. 12 is an embodiment that shows a certification test menu interface.The interface includes a list of injection sites and correspondingcontrols to initiate the test for the specified injection site. In someimplementations, simply activating the control to begin the test willinitiate the certification test. In some implementations, it may bedesirable to further identify or authenticate the trainee prior toinitiating the test to ensure no cheating is occurring. A furtheridentification authentication may include biometric identification, forout-of-band identification by an operator of the local display device110. To help verify the identity of the trainee, other identificationauthentication mechanisms may be used; such authentication mechanismsare understood and known by those in the relevant fields of endeavor.

FIG. 13 is an embodiment that provides a certification test result list.Illustratively, the training server 108 may analyze the test informationand provide a determination as to whether the trainee has achievedcertification. In some implementations, the injection training system100 provides levels of certification. FIG. 14 is an embodiment thatshows a certification interface for a trainee who has successfullycompleted a level 3 training for Botox®.

The certification information may be delivered in a variety of ways. Onedelivery method may be to provide a mailed certificate to the trainee'saddress as provided during the registration process. One delivery methodmay be to provide the certification information to an insurance provideron behalf of the trainee. This may be useful in helping insurersidentify appropriate reimbursement rates for procedures performed byclinicians, as well as to calculate premiums for the provider. Thecertification information delivery method may be via one or more socialmedia platforms such as Foursquare® or Facebook® or Yelp®. In suchimplementations, the trainee may provide account information to whichthe certification may be published upon successful completion. In anembodiment, the certification interface shown in FIG. 14 may include acontrol to cause the trainee to be added to a directory of certifiedproviders. This can provide further incentive for trainees to completecertifications, as inclusion in the directory may be a valuable form ofadvertising for their services and skills.

FIG. 15 is a process flow diagram for a method of providing injectiontraining according to an embodiment of the present disclosure. Themethod shown in FIG. 15 may be performed in one or more of the devicesshown herein. For example, the training server 108 may be configured toperform the method shown.

The method begins at node 1502 where a user is registered and then logsin. The registration process may include collecting information aboutthe trainee such as address, name, password, and the like. Registrationinformation may include, by way of non-limiting example, name, licensenumber, city, state, zip code, phone number, products used, andbiometric sensor used to verify the trainee's identity. Additionalinformation about the trainee's practice may be included such as typesand/or how many injections per week/patients per week. Backgroundinformation about the trainee such as area(s) of concern/training need,number of years injecting, and school attended may be obtained. Theregistration may also include legal information such as a user agreementincluding information about data capture and privacy. The registrationsystem may be configured to capture an electronic signature indicatingacceptance of the usage and data terms.

The login process, at node 1502, may include receiving one or more ofthe following: biometric sensor or camera information to identifytrainee; MD license/RN license data; user name; or password. The processat node 1502 may authenticate a user's fingerprint by using a scannerconnected to the processing unit 250 after the user has successfullyentered user name and password. The login process, at node 1502, caninclude authentication of the license number of the user via interactionof the training server 108 with the processing unit 250. Since the dataneeded is available on the processing unit 250, maintaining a networkconnection to the training server 108 is not necessary at this point. Aconnection may be established when the trainee or a facility employee istrying to add a new training or certification area for the trainee atthe time the training server 108 is not available.

It may be desirable to require fingerprint or other biometricverification for each trainee interaction with the training server. Insuch implementations, a communications link would be maintained, via theprocessing unit 250, with the training server 108 for interactionsthrough the training and certification head 200. If the trainee or otheruser desires to access the training server 108 away from the trainingand certification head 200, the biometric (e.g., fingerprint)identification may be received via a different biometric reader.Illustratively, the trainee (or trainee representative) may wish toaccess the training server 108 to purchase additional injection-trainingregions, to review training history, to mentor, or to authorize reviewof trainee status from locations remote from the training andcertification head 200. In some implementations, features may beselectively configured for access with biometric information based onthe feature, user, groups, or other permissions. For example, a traineemay wish to require biometric authentication for all interactions withhis or her data on the training server. In other implementations, it maybe required, such as by law or by a licensing entity, to protect certaininformation with biometrics. Accordingly, features which include suchdata may be protected, while other features made accessible without theneed for biometric security provisions.

After successful login, authentication of the license number of theuser, and/or biometric evaluation, a personal homepage will be displayedat node 1504. The personal homepage is dynamically generated to providecurrent information tailored to the logged-in user. The information mayinclude a training tip selected based on the user's performance during arecent training exercise. The information may include a new test orcertification that has become available, selected based on the user'sprevious tests, certifications, or indicated area of concern/trainingneed. The homepage may also include navigation controls to otherfeatures such as training analysis, training and certification history,training resources, training and certifications, settings, informationalcontent, injection training web resources, frequently asked questions,and the like.

The features related to training may include training educationalresources, drug selection tools and information, training progress andresults, current scores, ranking (e.g., where this trainee standsrelative to others nationally/regionally/locally/or by affinity group(e.g., same school)), injection technique (e.g., ninja versus whitebelt), training session time, real-time display of current needleproximity to target position and real-time feedback, and availabletrainings that need to be taken or can be taken by the trainee.Ancillary training resources, such as tutorials and videodemonstrations, may be included in the system and provided to thetrainee based on historical and/or demographic information associatedwith the trainee.

One example of a training resource is representational information forthe training site. In the example of a face, the representationalinformation includes human face content, such as anatomical information,animation of facial functions (e.g., muscle movement), and acomputer-aided drawing detailing various structures and structurallayers of the face. Analogous representational information of otherhuman, non-human, or inanimate objects may be provided to a trainee toallow that trainee to understand the behavior of the training site beingused.

Certification functionality may include features that allow the traineeto select and/or take a particular test. Illustratively, the test may berelated to a particular drug. The certification functionality mayinclude a listing of all available certifications and the option topurchase new certifications. The certification functionality can alsoinclude a display of certification results for the logged-in user.

The system may be configured to maintain historical information to allowtracking of activity and progress over time. The historical informationmay include, by way of non-limiting example, training date and time,session time, certifications, rankings, type of trainings taken, andcaptured data including: time, position, proximity, pressure for atest/training, geographical location (locator) information, maximumsession score, maximum training purchased, and maximum injectionsavailable.

At node 1506, injection sites purchased are presented. The injectionsites represent modules of injection training available to the logged-inuser. The injection sites may be provided upon receipt of payment. Theinjection sites may be provided for a limited period of time.

The injection training system 100 may receive a message including anidentifier for an injection site and a request for training. Such amessage causes, at node 1508, training to be performed for the requestedinjection site. The training may include anatomy training, viewingcontent, taking a quiz, or performing an exercise on a training andcertification head 200. The training may further provide feedback on thetraining such as a score at node 1510. If performed on the training andcertification head 200, the training information may be stored by theprocessing unit 250 and transmitted at a later point in time to thetraining server 108.

Once completed, the process may return to node 1504 to display thepersonal homepage as described above.

Returning to node 1506, a message may be received identifying aninjection site and the desire to perform a test (e.g., a certificationtest). At node 1520, the test is performed. Performing the test mayinclude further biometric identification at the training andcertification head 200 to ensure the user is correctly associated withthe certification test. Performing the test may include providing anexercise (e.g., drug and injection site) and waiting for data from thetraining and certification head 200 corresponding to performance of theexercise. At decision node 1524, the processing unit 250 may receive thetest data and compare it to an ideal test result to determine whethercertification criteria are met. Such comparison can be performed bynumerical and/or statistical analytical methods. The criteria may varybased on the drug and/or injection site. Illustratively, onenon-limiting example criterion can be the degree to which the receivedtest data matches the ideal test result. If the degree is below athreshold level, the trainee may not be given the certification. Thecertification criteria may also include an amount of time of training, anumber of training exercises, or other information for the trainee(e.g., license number, insurance number).

If it is determined, at decision node 1524, that the trainee has not metthe certification requirements, the process may continue to node 1508,as described above, to provide additional training. The additionaltraining may be tailored to the specific shortcomings with the mostrecent certification attempt. In some implementations, the process mayreturn to node 1504 to display the trainee's personalized homepage, asdescribed above.

If it is determined, at decision node 1524, that the trainee has met thecertification requirements, then at node 1526, the certification isapplied for on behalf of the trainee. The application of a certificationcan include creating a record in the data store 112 indicating thetrainee's qualification for the certification, along with a date ofcertification.

The process shown in FIG. 15 may continue to node 1530 where thecertification is published. Publication can include transmitting thecertification information to an insurance carrier, including the traineeon a public list of certified providers, and/or posting certification toa social media service such as Foursquare®, Facebook®, or Yelp®.Transmitting the certification information may be accomplished via anelectronic medium such as email, fax, web service, or the like.Transmitting the certification information may also include us of aphysical medium, such as mail or other courier services, in conjunctionwith physical production of the certification (e.g., print on demand,print to order, or batch print fulfillment).

Once the certification is published, the process may return to node1504, as described above.

FIG. 16 shows a process flow diagram for a method of generating atrainee profile according to an embodiment of the present disclosure.The method shown in FIG. 16 may be implemented in whole or in part byone or more of the devices described above, such as the training server108.

At node 1602, a request for a trainee profile is received. The requestincludes an identification of a trainee for which the profile is to begenerated. In some implementations, this identification information maybe obtained from a session established upon the trainee's login to thesystem. In some implementations, the request may be generated by a localdisplay device 106 upon selection of a trainee to supervise. Forexample, the local display device 106 may provide an interface listingthe trainees at a particular training center. The local display device106 may receive an indication of one trainee of interest and transmitthis to the server 108 for generating a profile.

At node 1604, recent training and/or test data for the trainee isretrieved. The recent data may be training or test data uploaded fromone or more training and certification heads 200, from the data store112, or based on the information received in the request at node 1602.The retrieval may be further based on a system configuration indicatingthe period of time defining “recent.” For example, in oneimplementation, recent data may be identified as data collected within anumber of weeks, while in other implementations the recent data may beidentified as data collected within a number of hours, months, years, orother measures of time. The configuration may further define a maximumnumber of records to retrieve.

At node 1606, resources accessed by the trainee are retrieved. Theresources may include training resources, certification resources,general information resources, or any other data provided by or throughthe injection training system 100.

At node 1608, injection information for the trainee is obtained.Examples of the training injection information can include the number ofinjections performed by the trainee and the injection sites on which thetrainee has trained. The injection information may comprise training ortest data uploaded from one or more training and certification heads200. The injection information may be obtained from the data store 112and/or the memory 262.

At node 1610, training purchased by the identified trainee is retrieved.The training may be retrieved from the data store 112. In someimplementations, information about a training module is retrieved ratherthan the training content. The information about the training mayinclude identification information that may be used, such as by aprocessing unit 250, to obtain the training content for a training andcertification head 200. In some implementations, this information abouta training module may be referred to as training metadata.

At node 1612, certifications for the identified trainee are retrieved.The certification information may include certifications obtained,certifications attempted but not successfully obtained, certificationsavailable for the trainee to take, and/or certifications which may beaccessed upon satisfaction of one or more conditions (e.g., payment orcompletion of required training).

At node 1614, analytics may be generated for the identified trainee. Theanalytics may be based on the retrieved information. The analytics caninclude obtaining aggregated information for other trainees andcomparing the aggregated information to the trainee's information. Theanalytics may identify training resources to improve one or more aspectof the trainee's injection technique. The identification may be based onavailable training resources, training metadata, injection information,and recent training and/or test data, to name a few.

At node 1618, the trainee profile is generated. The trainee profile maybe generated in a computer-readable format such as hypertext markuplanguage, extensible markup language, or another structured orsemi-structured machine-readable format. In some implementations,generation of the trainee's profile at node 1618 may include providing adisplay interface including the trainee profile. The profile may includethe retrieved information from, for example, the data store 112. Theprofile may include processed versions of the retrieved information. Theprocessing may include selectively including one or more informationelements, including elements in a particular order (e.g., priorityranking). The analytics may also be included in the trainee profile. Insome implementations, the trainee profile may be used to generate apersonal homepage for the trainee.

FIG. 17 shows a process flow diagram for a method of injection training.The method may be implemented in whole or in part using one or more ofthe devices described above, such as the training server 108.

At node 1702, an electronic message identifying a trainee is received.The message may include a trainee identifier or identifying informationsuch as a name or license number.

At node 1704, a training module is transmitted to a processing unit 250.The training module identifies a target injection profile for specifiedinjection site and injectable substance. The target injection profilerepresents the ideal or “perfect” injection for the selected site andsubstance.

At node 1706, after completion of said training module, injection datafor the trainee for the training module is received. The injection dataidentifies one or more characteristic of a syringe 210 during thetraining. Characteristics may include location, depth, pressure, plungerlocation, time, speed, and the like. The characteristics may be receivedfrom the syringe 210, from one or more sensors 206, and/or from aprocessing unit 250. The injection data is associated with a trainingapparatus 200 upon which said training module was performed. In someimplementations, this may include providing a device identifier for thetraining apparatus 200.

At node 1708, feedback is provided based at least in part on saidreceived injection data. The feedback may be targeted to the trainee andmay include an indication of certification status, training status,additional training resources, or the like. The feedback for a traineemay take the form of a trainee profile as described above. In someimplementations, the feedback may include feedback targeted to thetraining apparatus. For example, the feedback may identify maintenanceneeded for the training apparatus 200 (e.g., training portion 202,syringe 210, processing unit 250, etc.).

The disclosed injection training system 100 provides the capability tomonitor and evaluate injection training activity in a manner thatexceeds the level of instruction and performance evaluation offered bytraditional injection training practices and environments. Inparticular, the injection training system 100 collects data that can beused to analyze various aspects of the trainee's performance, bothduring the injection training session and after the session iscompleted. Illustratively, the injection training system 100 senses,displays, and records the position and orientation of the syringe 210,including the syringe needle, relative to the training apparatus 200during the delivery of the training injection. Metrics are collected bythe injection training system 100 during training injections to monitor,evaluate, and assess various aspects of the injection performed by thetrainee. Some such metrics, by way of non-limiting example, include adescription of the dynamic motion of the syringe, including position andorientation information of the syringe and the syringe needle relativeto the training apparatus throughout the training injection; the angleof approach of the syringe needle relative to the training apparatus;the angle of entry of the syringe needle into the training apparatus;the depth of penetration of the needle within the training apparatus;the amount of force applied by the syringe to the training apparatus;the amount of therapeutic agent delivered (either by simulation ofdelivery or by actual delivery) to the training apparatus; the dynamicdescription of displacement of the syringe plunger during the traininginjection; the amount of force applied to the syringe plunger during thetraining injection; the rate of flow of the therapeutic agent delivered(either by simulation or by actual delivery) to the training apparatus;the proximity of the delivered injection relative to the targetinjection site; and the anatomical structures affected by the traininginjection.

By processing the collected metrics, the disclosed injection trainingsystem 100 can present, on for example, the display device 106, acomputer-generated graphical depiction of the training injection. Theinjection training system 100 possesses a digital model of the trainingapparatus 200 based on information corresponding to the anatomicalstructure represented by the training apparatus 200. By way ofnon-limiting example, the digital model can include target tissue(individual muscles) and details of vital structures (which may also bereferred to as vital tissue) such as, for example, arteries, veins,nerves, and skeletal portions, that are to be avoided or accommodatedduring the training injection. The display device 106 can graphicallypresent, during the injection training and afterwards, the location ofthe needle tip relative to the training apparatus 200 as the needle tippenetrates the training apparatus 200. The display device 106illustrates portions of the anatomy in the vicinity of the desiredinjection site. In particular, vital tissue and muscle are representeddigitally on the display device 106. Advantageously, the user can view atarget site, a proximity to the target site, and nearby vital tissues orstructures. In some embodiments, visual and/or aural signals aredelivered to the trainee as indications of the needle tip's proximity tothe target site. For example, a target indicator may be displayed tographically illustrate the needle's present location relative to thetarget location. Similarly, a tone pitch or frequency of utterance, orother such characteristic can change in response the needle's positionrelative to the target location, thereby providing target acquisitionfeedback to the trainee without requiring the trainee to view thedisplay device 106. In another embodiment of the present disclosure, avisible display, a light, or a tactile sensor can be provide on thesyringe 210 to provide such indication. During an injection the displaydevice 106 can graphically illustrate the different anatomical skin andtissue layers as the needle tip penetrates each layer. For example, thiscan be accomplished by graphically revealing different anatomical layersas the layers are penetrated by the needle. The different anatomicallayers can be labeled or provided with different textures or colors toindicate a new layer is shown. In an embodiment, the trainee cannavigate between the graphical representations of the differentanatomical layers as desired.

The real-time graphical depiction of the training injection, aspresented on the display device 106, provides information to help thetrainee effectively deliver the desired injection. Illustratively, thetrainee may alter the view of the graphical depiction to providedifferent perspectives of the training injection as it is beingperformed. The trainee may select views that depict different layers orportions of the anatomy. For example, the trainee might select to viewon the display device 106 vital structures that must be avoided.Additionally, the trainee can zoom in, zoom out, and rotate the view ofthe graphical depiction to better visualize the injection as it is beingperformed or afterwards. By comparing the position of the syringe needletip, based on the determined position and orientation of the syringe, tothe target tissues and the vital structures illustrated on the displaydevice, proximity to a desired injection target can be established. Thisproximity to the desired target and to vital structures can serve as thebasis for evaluating the skill of the injection trainee.

The disclosed injection training system captures and stores theinformation collected during injection training sessions for subsequentreview, evaluation and analysis. Such information includes the recordedposition and orientation information associated with the dynamic motionof the syringe, relative to the training apparatus, during traininginjections. Additionally, processed information associated with atraining session may be stored for subsequent review, evaluation andanalysis. In an embodiment, the training session information is stored,in aggregate, on the data store 112 and is accessible by the trainingserver 108 to perform analytics on the aggregated data. Illustratively,by way of non-limiting example, types of information that may beaccessed by the training server 108 and maintained in the data store 112include: training date and time; location; trainee; authorization code;session time; maximum score; maximum ranking within a group (national,region, city, affinity); injection time; amount of pressure applied tothe syringe 210; track of the needle tip during injection; in whichmuscle, nerve, or artery the syringe 210 is injected; pass/fail rates;percentage of injections versus other trainees; number of times aparticular piece (or combination of pieces) of training equipment hasbeen used for an injection; behavior of trainee “using” the syringe 210;report feedback on the trainee's performance as compared to an expert inthe field (e.g., the Dr. Jean Carruthers technique); and how thistrainee “injects” versus others who have undergone the same training.

The training server 108 can be configured to analyze the aggregatedtraining information to identify, among other things, patternsreflective of behaviors among the various trainees. Illustratively, byway of non-limiting example, data can be mined for trainee performancecharacteristics, including correlation between injection behavior andinjection performance, correlation between training materials completedand injection performance, correlation between training location andinjection performance, correlation between trainee's education level andinjection performance, correlation between the amount of time taken tocompete training materials and injection performance, to name a few.Additionally, the data can be analyzed to identify the trainingsequences and injection techniques that are used by the highestperforming trainees. Such analysis can be used to modify trainingmaterials and/or training sequences to improve overall performance oftrainees who used the injection training system 100. The aggregated datamay also be mined to identify training equipment in need of maintenanceor replacing. The data may be mined further to identify effectivetraining resources and/or training centers.

FIG. 18 is a functional block diagram of an embodiment of a generalpurpose computing system suitable for use in implementing the disclosedsystems and in executing the disclosed methods and the executableinstructions stored on the non-transitory, computer-readable media forinjection training in accordance with various embodiments of the presentdisclosure. By way of illustration, the computing system includes acomputing device 1800. The computing device 1800 can take one or more ofdifferent forms, including, by way of non-limiting examples, a laptopcomputer, a stand-alone personal computer, a server, a tablet, aworkstation, a handheld device, a mobile device (such as a smartphone),and a consumer electronic device (such as a video game console), to namea few. The computing device 1800 can be a stand-alone device, or it canbe configured to be part of a computing network, a computing cluster, acloud-based computing infrastructure, or the like.

In a basic configuration, the computing device 1800 can include one ormore processors 1802 and one or more memory devices 1804. The one ormore processors 1802 can be configured to execute instructions and toprocess data to perform one or more functions, such as the methods andthe executable instructions stored on computer-readable media disclosedherein. Illustratively, the one or more processors 1802 may include,without limitation, two or more processing cores on a single processingchip, two or more separate processor chips, or both. In someembodiments, the computing device 1800 can also include one or moreadditional or specialized processors such as, for example, the sensorprocessor 252, the syringe processor 254, or a graphics processor (notshown) to perform graphics processing functions that can be divertedfrom the one or more processors 1802 to improve performance and/or torelieve their workload. The memory 1804 can be arranged in a hierarchyand can include one or more levels of cache. The memory 1804 may includeone or more memory devices that store data, including withoutlimitation, volatile memory such as random access memory (RAM),non-volatile memory, such as and read-only memory (ROM), flash memory,etc., or a combination of volatile and non-volatile memory.

The computing device 1800 can also include one or more input and output(I/O) connections, such as USB connections, display ports, proprietaryconnections, and others to connect to various devices to provide inputsand outputs to the computing device 1800. The I/O device(s) 1806 mayinclude one or more components that allow a user of the computing device1800 to interface with applications executing in the computing device1800. For example, the I/O device(s) 1806 may include devices such as akeyboard, a mouse, a touch pad, a touch screen, a microphone, anaccelerometer, a camera, or any other user input device configurable towork with the computing device 1800. The I/O device(s) 1806 may alsoinclude, for example, a display (e.g., an LCD display, a CRT display, anelectronic ink display, or a plasma display, to name a few), a printer,a speaker, or any other output devices configurable to work with thecomputing device 1800.

The computing device 1800 can also include one or more network interfacedevices 1808 that allow the computing device 1800 to communicate withother computers and applications. The one or more network interfacedevices 1808 may include any communication device for sending andreceiving data across a network, including but not limited to, a networkinterface card, a modem, or another network adapter capable oftransmitting and receiving data over a network. Communication protocolconnections can include, without limitation, an Ethernet interface, awireless interface, a bus interface, a storage area network interface,and a proprietary interface. Communication connections established viathe network interface devices 1808 can be used to connect the computingdevice 1800 to a computer network. A computer network is atelecommunications network that enables computers, and possibly otherdevices, to exchange data and share resources along data connections.There are many different types of computing networks that exhibit avariety of characteristics such as topology, connection method, andscale. Examples of computer networks include a local area network, awide area network, the Internet, or other networks.

The computing device 1800 can also include one or more mass storagedevices 1810. The one or more mass storage devices 1810 can be removableor non-removable, and can include, without limitation, a magneticstorage device (e.g., a hard disk), an optical storage medium (e.g., acompact disc (CD) drive or a digital versatile disc (DVD) drive), ahigh-definition optical storage medium, an electronic storage device(e.g., an erasable programmable read-only memory (EPROM) or a flashdrive), solid-state memory, flash storage devices, or other data storagedevices known in the art. Computer storage media can include volatile,non-volatile, removable, and non-removable media configured to storeinformation such as, for example, computer-readable instructions, dataarrangements, program components, or other information. Illustratively,computer storage media can include, without limitation, random accessmemory (RAM), read-only memory (ROM), electrically erasable programmableread-only memory (EEPROM), flash memory, solid-state memory, CD-ROM, DVDmemory, or other optical storage, magnetic cassettes, magnetic tape,magnetic disk storage or other magnetic storage devices, a universalserial bus (USB) flash drive, a flash memory card, or other flashstorage devices, or any other storage medium that may be configured tostore computer-readable information and that can be read by thecomputing device 1800. The one or more memory devices 1804 and the oneor more mass storage devices 1810 may be employed to store a workingcopy and a permanent copy of programming instructions, illustrated asinstructions 1814 and 1816, respectively, for implementing variousaspects of the embodiments of the present disclosure. The components ofthe computing device 1800 can be coupled together by way of a bus 1812,which may represent one or more buses.

The word “exemplary” is used herein to mean “serving as an example,instance, or illustration.” Any embodiment described herein as“exemplary” is not necessarily to be construed as preferred oradvantageous over other embodiments. Various aspects of the novelsystems, apparatuses, and methods are described more fully hereinafterwith reference to the accompanying drawings. This disclosure may,however, be embodied in many different forms and should not be construedas limited to any specific structure or function presented throughoutthis disclosure. Rather, these aspects are provided so that thisdisclosure will be thorough and complete, and will fully convey thescope of the disclosure to those skilled in the art. Based on theteachings herein, one skilled in the art may appreciate that the scopeof the disclosure is intended to cover any aspect of the novel systems,apparatuses, and methods disclosed herein, whether implementedindependently of, or combined with, any other aspect described. Forexample, an apparatus may be implemented or a method may be practicedusing any number of the aspects set forth herein. In addition, the scopeof the described features is intended to cover such an apparatus ormethod which is practiced using other structure, functionality, orstructure and functionality in addition to or other than the variousaspects disclosed herein. It may be understood that any aspect disclosedherein may be embodied by one or more elements of a claim.

Although particular aspects are described herein, many variations andpermutations of these aspects fall within the scope of the disclosure.Although some benefits and advantages of the preferred aspects arementioned, the scope of the disclosure is not limited to particularbenefits, uses, or objectives. Rather, aspects of the disclosure arebroadly applicable to different injection training technologies, systemconfigurations, networks, and transmission protocols, some of which areillustrated by way of example in the figures and the includeddescription of the preferred aspects. The detailed description anddrawings are merely illustrative of the disclosure rather than limiting,the scope of the disclosure being defined by the appended claims andequivalents thereof.

The terms “processor” and “processor module,” as used herein are a broadterms, and are to be given their ordinary and customary meaning to aperson of ordinary skill in the art (and are not to be limited to aspecial or customized meaning), and refer without limitation to acomputer system, state machine, processor, or the like designed toperform arithmetic or logic operations using logic circuitry thatresponds to and processes the basic instructions that drive a computer.In some embodiments, the terms can include ROM and/or RAM associatedtherewith.

As used herein, the term “determining” encompasses a wide variety ofactions. For example, “determining” may include calculating, computing,processing, deriving, investigating, looking up (e.g., looking up in atable, a database or another data structure), ascertaining and the like.Also, “determining” may include receiving (e.g., receiving information),accessing (e.g., accessing data in a memory) and the like. Also,“determining” may include resolving, selecting, choosing, establishing,and the like.

As used herein, the term “message” encompasses a wide variety of formatsfor transmitting information. A message may include a machine readableaggregation of information such as an XML document, fixed field message,comma separated message, or the like. A message may, in someimplementations, include a signal utilized to transmit one or morerepresentations of the information. While recited in the singular, itwill be understood that a message may becomposed/transmitted/stored/received/etc. in multiple parts.

Any reference to an element herein using a designation such as “first,”“second,” and so forth does not generally limit the quantity or order ofthose elements. Rather, these designations may be used herein as aconvenient method of distinguishing between two or more elements orinstances of an element. Thus, a reference to first and second elementsdoes not mean that only two elements may be employed there or that thefirst element must precede the second element in some manner. Also,unless stated otherwise a set of elements may include one or moreelements.

Conditional language used herein, such as, among others, “can,” “could,”“might,” “may,” “e.g.,” and the like, unless specifically statedotherwise, or otherwise understood within the context as used, isgenerally intended to convey that certain embodiments include, whileother embodiments do not include, certain features, elements and/orstates. Thus, such conditional language is not generally intended toimply that features, elements and/or states are in any way required forone or more embodiments or that one or more embodiments necessarilyinclude logic for deciding, with or without author input or prompting,whether these features, elements and/or states are included or are to beperformed in any particular embodiment.

Depending on the embodiment, certain acts, events, or functions of anyof the methods described herein can be performed in a differentsequence, can be added, merged, or left out altogether (e.g., not alldescribed acts or events are necessary for the practice of the method).Moreover, in certain embodiments, acts or events can be performedconcurrently, e.g., through multi-threaded processing, interruptprocessing, or multiple processors or processor cores, rather thansequentially.

The various illustrative logical blocks, modules, circuits, andalgorithm steps described in connection with the embodiments disclosedherein can be implemented as electronic hardware, computer software, orcombinations of both. To clearly illustrate this interchangeability ofhardware and software, various illustrative components, blocks, modules,circuits, and steps have been described above generally in terms oftheir functionality. Whether such functionality is implemented ashardware or software depends upon the particular application and designconstraints imposed on the overall system. The described functionalitycan be implemented in varying ways for each particular application, butsuch embodiment decisions should not be interpreted as causing adeparture from the scope of the disclosure.

The various illustrative logical blocks, modules, and circuits describedin connection with the embodiments disclosed herein can be implementedor performed with a general purpose processor, a digital signalprocessor (DSP), an application specific integrated circuit (ASIC), afield programmable gate array (FPGA) or other programmable logic device,discrete gate or transistor logic, discrete hardware components, or anycombination thereof designed to perform the functions described herein.A general purpose processor can be a microprocessor, but in thealternative, the processor can be any conventional processor,controller, microcontroller, or state machine. A processor can also beimplemented as a combination of computing devices, e.g., a combinationof a DSP and a microprocessor, a plurality of microprocessors, one ormore microprocessors in conjunction with a DSP core, or any other suchconfiguration.

The blocks of the methods and algorithms described in connection withthe embodiments disclosed herein can be embodied directly in hardware,in a software module executed by a processor, or in a combination of thetwo. A software module can reside in RAM memory, flash memory, ROMmemory, EPROM memory, EEPROM memory, registers, a hard disk, a removabledisk, a CD-ROM, or any other form of computer-readable storage mediumknown in the art. An exemplary storage medium is coupled to a processorsuch that the processor can read information from, and write informationto, the storage medium. In the alternative, the storage medium can beintegral to the processor. The processor and the storage medium canreside in an ASIC. The ASIC can reside in an electronic device. In thealternative, the processor and the storage medium can reside as discretecomponents in an electronic device.

While the above detailed description has shown, described, and pointedout novel features as applied to various embodiments, it will beunderstood that various omissions, substitutions, and changes in theform and details of the devices or algorithms illustrated can be madewithout departing from the spirit of the disclosure. As will berecognized, certain embodiments of the disclosures described herein canbe embodied within a form that does not provide all of the features andbenefits set forth herein, as some features can be used or practicedseparately from others. The scope of certain disclosures disclosedherein is indicated by the appended claims rather than by the foregoingdescription. All changes which come within the meaning and range ofequivalency of the claims are to be embraced within their scope.

What is claimed is:
 1. An injection training system configured fortraining of a facial injection technique, the system comprising: asyringe having a syringe body and a plunger, the plunger configured tomove relative to the syringe body, the syringe body comprising aproximal end and a distal end, the syringe further comprising a flangeportion disposed at or near the proximal end, and a needle coupled tothe distal end; a training apparatus in the form of an anatomical modelof a human head configured to receive a facial training injectionperformed by a user using the syringe, the training apparatus comprisinga layer of synthetic or simulated tissue, the needle of the syringeconfigured to penetrate the layer of tissue; a location sensing systemincluding a first portion and a second portion, the first portion andthe second portion working together to determine a position andorientation of the syringe needle, the first portion coupled to thesyringe and configured to move with the syringe, the second portionbeing stationary relative to the training apparatus, wherein at leastone of the first or second portion is at least configured to measureinformation corresponding to characteristics of a magnetic field; and aprocessing unit in electrical communication with the location sensingsystem, wherein the location sensing system is configured to determineand transmit to the processing unit information related to the positionand orientation of the syringe needle, the processing unit configured tocalculate the position and orientation of the syringe needle relative tothe training apparatus, the determined position and orientationincluding at least a depth and location of the injection associated withthe layer of tissue of the training apparatus, and the processing unitfurther configured to cause a display device to display feedback on howthe user performed in the facial training injection, wherein thefeedback comprises a three-dimensional graphical depiction of thetraining injection based at least in part on the calculated position andorientation of the syringe relative to the training apparatus, whereinthe three-dimensional graphical depiction comprises a digital model ofthe syringe and the digital model of the training apparatus, the digitalmodel of the training apparatus comprising a plurality of differentanatomical layers, the three-dimensional graphical depiction furthercomprising a simulated delivery of therapeutic agent to the digitalmodel of the training apparatus and a dynamic position of the plunger inreal-time.
 2. The injection training system of claim 1, wherein thefeedback further comprises a comparison between the calculated positionand orientation of the syringe needle relative to the training apparatusand a test template.
 3. The injection training system of claim 1,wherein the three-dimensional graphical depiction of the traininginjection is configured to be displayed during the training injection.4. The injection training system of claim 1, wherein thethree-dimensional graphical depiction of the training injection isconfigured to be displayed in replay after the training injection iscompleted.
 5. The injection training system of claim 4, wherein theprocessing unit is configured to cause the feedback to be displayed onlyafter the training injection is completed when the system is in a testmode.
 6. The injection training system of claim 1, wherein theprocessing unit is configured to cause the display device to display theplurality of different anatomical layers as the needle penetrates eachanatomical layer during the training injection.
 7. The injectiontraining system of claim 6, wherein the display device is configured todisplay one or more of the different anatomical layers in response touser commands.
 8. The injection training system of claim 7, wherein aview of the three-dimensional graphical depiction on the display deviceis configured to be enlarged, rotated, and/or panned in response to usercommands.
 9. The injection training system of claim 1, wherein theprocessing unit is configured to cause the display device to reveal eachone of the plurality of anatomical layers as the needle penetrates thatanatomical layer during the training injection.
 10. The injectiontraining system of claim 1, wherein the display device is configured todisplay the plurality of different anatomical layers in different colorsand/or textures.
 11. The injection training system of claim 1, whereinthe processing unit is configured to cause the display device to displayproximity of the needle to vital anatomical structures to be avoided bythe needle.
 12. The injection training system of claim 1, wherein a viewof the three-dimensional graphical depiction on the display device isconfigured to be changed to allow better visualization of the traininginjection during and/or after the training injection is performed. 13.The injection training system of claim 12, wherein the view isconfigured to be enlarged, rotated, and/or panned in response to usercommands.
 14. The injection training system of claim 1, wherein thethree-dimensional graphical depiction comprises an injection targetindicator.
 15. The injection training system of claim 1, wherein thefirst portion comprises a magnetometer.
 16. The injection trainingsystem of claim 1, wherein the first portion is coupled to the syringebody and the plunger.
 17. The injection training system of claim 16,wherein the processing unit is further configured to calculate aposition of the plunger relative to the syringe needle.
 18. Theinjection training system of claim 1, wherein the training apparatuscomprises a plurality of layers of different stiffness.
 19. Theinjection training system of claim 1, wherein the first portion furthercomprises a light source located at or near the distal end of thesyringe body, wherein light from the light source is emitted through atip of the needle, and wherein the second portion comprises at least onecamera inside a cavity of the training apparatus, the at least onecamera configured to detect the emitted light.
 20. An injection trainingsystem configured for training of a facial injection technique, thesystem comprising: a syringe having a syringe body and a plunger, theplunger configured to move relative to the syringe body, the syringebody comprising a proximal end and a distal end, the syringe furthercomprising a flange portion disposed at or near the proximal end, and aneedle coupled to the distal end; a training apparatus in the form of ananatomical model of a human head configured to receive a facial traininginjection performed using the syringe, the training apparatus comprisinga layer of synthetic or simulated tissue, the needle of the syringeconfigured to penetrate the layer of tissue; a location sensing system,at least a portion of the location sensing system being coupled to thesyringe body and the plunger, and configured to move with the syringe,at least another portion of the location sensing system being stationaryrelative to the training apparatus, wherein the location sensing systemis at least configured to measure information corresponding tocharacteristics of a magnetic field; and one or more processors inelectrical communication with the location sensing system, wherein theat least one portion and the at least another portion of the locationsensing system are configured to work together to determine and transmitto the one or more processors information related to the position andorientation of the syringe needle, the location sensing system furtherconfigured to determine and transmit to the one or more processorsinformation related to a dynamic position of the plunger relative to thesyringe needle, the one or more processors configured to calculate theposition and orientation of the syringe needle relative to the trainingapparatus and the dynamic position of the plunger relative to thesyringe needle during the facial training injection, the calculatedposition and orientation of the syringe needle relative to the trainingapparatus including at least a depth and location of the injectionassociated with the layer of tissue of the training apparatus, and theone or more processors further configured to cause a display device todisplay feedback on how the user performed in the facial traininginjection, wherein the feedback comprises a three-dimensional graphicaldepiction of the training injection based at least in part on thecalculated position and orientation of the syringe relative to thetraining apparatus and the dynamic position of the plunger relative tothe syringe needle, wherein the three-dimensional graphical depictioncomprises a digital model of the syringe and the digital model of thetraining apparatus, the digital model of the training apparatuscomprising a plurality of different anatomical layers, the digital modelof the syringe comprising a digital model of the plunger moving inreal-time relative to a digital model of the syringe needle based on thedynamic position of the plunger relative to the syringe needle duringthe facial training injection.
 21. The injection training system ofclaim 20, wherein the three-dimensional graphical depiction of thetraining injection is configured to be displayed during the traininginjection.
 22. The injection training system of claim 20, wherein thethree-dimensional graphical depiction of the training injection isconfigured to be displayed in replay after the training injection iscompleted.
 23. The injection training system of claim 22, wherein theone or more processors are configured to cause the feedback to bedisplayed only after the training injection is completed when the systemis in a test mode.
 24. The injection training system of claim 20,wherein the display device is configured to display one or more of thedifferent anatomical layers in response to user commands.
 25. Theinjection training system of claim 20, wherein a view of thethree-dimensional graphical depiction on the display device isconfigured to be enlarged, rotated, and/or panned in response tocommands from a user.
 26. The injection training system of claim 20,wherein the location sensing system comprises a magnetometer.
 27. Aninjection training system configured for training of a facial injectiontechnique, the system comprising: a syringe having a syringe body and aplunger, the plunger configured to move relative to the syringe body,the syringe body comprising a proximal end and a distal end, the syringefurther comprising a flange portion disposed at or near the proximalend, and a needle coupled to the distal end, wherein the syringecomprises first location sensing means; a training apparatus in the formof an anatomical model of a human head configured to receive a facialtraining injection performed using the syringe, the training apparatuscomprising a layer of synthetic or simulated tissue, the needle of thesyringe configured to penetrate the layer of tissue; second locationsensing means that is stationary relative to the training apparatus,wherein at least one of the first or second location sensing means isconfigured to measure information corresponding to characteristics of amagnetic field; and one or more processing means in electricalcommunication with at least one of the first or second location sensingmeans, wherein the first and second location sensing means areconfigured to work together to determine and transmit to the one or moreprocessing means information related to the position and orientation ofthe syringe needle, the one or more processing means configured tocalculate the position and orientation of the syringe needle relative tothe training apparatus and a real-time displacement of the plungerrelative to the syringe needle during the facial training injection, thecalculated position and orientation including at least a depth andlocation of the injection associated with the layer of tissue of thetraining apparatus, and the one or more processing means furtherconfigured to cause a display device to display feedback on how the userperformed in the facial training injection, wherein the feedbackcomprises a three-dimensional graphical depiction of the traininginjection based at least in part on the calculated position andorientation of the syringe relative to the training apparatus and thereal-time displacement of the plunger relative to the syringe needle,wherein the three-dimensional graphical depiction comprises a digitalmodel of the syringe and the digital model of the training apparatus,the digital model of the training apparatus comprising a plurality ofdifferent anatomical layers, and the digital model of the syringecomprising the real-time displacement of the plunger relative to thesyringe needle.
 28. The injection training system of claim 27, whereinthe three-dimensional graphical depiction of the training injection isconfigured to be displayed during the training injection and/or inreplay after the training injection is completed.
 29. The injectiontraining system of claim 27, wherein the one or more processing meansare configured to cause the display device to display one or more of thedifferent anatomical layers in response to user commands.
 30. Theinjection training system of claim 27, wherein the one or moreprocessing means are configured to cause a view of the three-dimensionalgraphical depiction on the display device to be enlarged, rotated,and/or panned in response to user commands.